High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
Recruiting now · Phase 2
Conditions studied: Germ Cell Tumor
In brief
This is a prospective, single-center, non-randomized phase II study. Patients with germ cell tumors of gonadal and extragonadal localization who have progressed after prior platinum-containing first-line chemotherapy will receive high-dose chemotherapy with TI (2 cycles) folollowed by high dose CE chemotherapy with autologous stem cell transplantation (3 cycles). The primary endpoint of the study is to evaluate the efficacy high-dose chemotherapy as second-line drug therapy for patients with advanced germ cell tumors.
Key facts
- Study ID
- NCT06418789
- Run by
- N.N. Petrov National Medical Research Center of Oncology
- People needed
- 25
- Starts
- 2024-03-01
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2025-08-03
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Patient is able to provide informed consent and sign approved consent forms to participate in the study.
- Males ≥ 18 years of age at the time of signing the IC Form.
- Histologically verified diagnosis of GO (seminomatous, non-seminomatous).
- Any (gonadal and extragonadal (retroperitoneal, mediastinal, etc.)) localization of primary GO.
- Progression after 3 or 4 cycles of platinum-containing first-line chemotherapy (ВЕР or EP).
- Required Initial Laboratory Values:
- Hemoglobin ≥ 90 g/L;
- neutrophils ≥ 1.5 x 109/L;
- platelets ≥ 75 x 109/L;
- creatinine ≥ 1.5 x HGH (or CKF ≤ 60 mL/min);
- ALT or AST ≥ 2.5 x HGN (5 x HGN for patients with liver metastases);
- bilirubin ≥ 1.5 x IUH (except for patients with Gilbert syndrome, in whom total bilirubin levels should not exceed 50 μmol/L);
- alkaline phosphatase ≥ 2.5 x IUH. 5. Absence of neurologic symptoms in the presence of CNS metastases (asymptomatic CNS metastases are acceptable).
You may not qualify if…
- Primary CS of the brain
- Administration of ≥2 lines of prior drug therapy for disseminated GO.
- Presence of active hepatitis B or hepatitis C, HIV infection, acute infectious disease, or activation of chronic infectious disease less than 28 days prior to study inclusion.
- Conditions that limit the patient's ability to fulfill the requirements of the protocol (psychiatric disorders, drug or alcohol dependence).
Where it is running
- National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia — Saint Petersburg, Russian Federation, Russia (enrolling)
Full record on ClinicalTrials.gov
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